Accepted answer
1.6 percentage points, and the direction is the informative half. Medutest reports 98.4 per cent and the certificate 96.8, so the independent figure is higher. As impurity that is 1.6 per cent against 3.2 — 0.5 times as much unassigned area, which is the unusual direction and worth a second look at the integration. Method differences usually make the independent number the lower one, so an independent result above the certificate points at integration limits, a different wavelength, or a different definition of the main peak rather than at a better vial. Ask both parties for the method section before you decide which figure is wrong, because the answer is often neither.
Start from what the detector sees, because that tells you what the number means.
Integration of the shoulder — whether you use perpendicular drop or tangent skim — determines what area gets assigned to the main peak versus the impurity table.
Reconciling gross mass to label claim
| Component | Typical share | Counted in purity? | Counted in content? |
|---|
| Target peptide | 88–94 % | Yes, as main peak | Yes |
| Related impurities | 1–3 % | Yes, as other peaks | No |
| Counter-ion (TFA or acetate) | 2–8 % | No | No |
| Residual water | 2–6 % | No | No |
| Bulking agent, if present | 0–40 % | No | No |
Tailing factor measures peak shape, and a badly tailing peak spreads into the region where small impurities live, forcing tangent-skim integration that assigns tail area to the main peak.
The ICH Q3A impurity thresholds and the relevant pharmacopoeial chapters all specify method validation requirements that almost no research-grade certificate claims to meet.
The limitation is that single-digit micro-impurities become invisible at typical reporting thresholds, so "no impurities detected" means "none above one in two thousand."
If you are ranking vendors, specify a method and have all samples tested at the same place.
edited 25 Sept 2025 by kwn_analytical — added the method parameters